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ISO AUDIT?
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ISO AUDIT?
Need an internal audit?
Contact us...

3 reasons you might find it hard to get ISO 9001 Certification,

1) You hire a consultant who isn’t clear about how to effectively implement management standards such as ISO 9001 in your particular business or industry …
2) You hire a consultant who isn’t experienced enough to see the project through to completion in a timely manner … or …
3) You try to do it yourself while juggling all your other responsibilities.
Notice none of these reason have anything to do with what your business actually does, how big or small it is, or how long you’ve been in business?
That’s because if you’re in business, and if you’ve conducted at least one transaction — regardless of the size — you can gain certification for any of the three management systems mentioned above.

ISO 13485 2016 Overview Presented by Perry Johnson Registrars on October 14th, 2016

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What will happen to company once its IMS (ISO) certificate will not be renewed or can't get a re-certification due to major non-compliance issues? ....................................................................... First, of all you will lose your certificate, some of the consequences are:

1- Affecting your reputation in Market as this is not a very usual thing, you may lose some of your clients if they require ISO from vendors

2- you have to remove all the logos which indicate that you have ISO from all you communication (Email, Letters, website, Etc...), also the logos on company products if an

3- any failure to do step number 2, could reach to court if you mention that you are certified but you are really not. its really hard to perform step number 2 especially if you have products in market says that you have ISO, you need possibly to recall it all (check with certification body)

4- some of the certification bodies, do an announcement in newspaper to inform community that X company have lose its ISO certificate due to Non compliance with standard as legal action. (check with certification body)

5- while you said its an IMS, possibly, ISO 9001, OHSAS 18001 and ISO 14001, if the Major is related to Risk Assessment in OHSAS and ISO 14001, and all the elements of QMS ISO 9001 are fine, you may ask them to change the scope of certificate at least to maintain the minimum standard.

hope its help... to understand how impertant of ISO /QMS standards to your company..!

What are the requirements of ISO 9001 standard ?

1. Determine the internal and external context that affects the organization
2. Determine the need and expectations of interested parties
3. Determine the scope of quality management system
4. Determine the input required and output expected of these processes
5. Determine interaction of these process
6. Determine the criteria ,methods, including measurement and related performance
indicators needed to ensure effective operation and control these processes
7. Determine the resources needed for these processes and ensure their availability
8. Assigning responsibilities and authorities for these processes by adopting a Stakeholder approach to quality management.
9. Determine risks and opportunities in accordance with these process and appropriate actions to address them.
10. Determine the methods to monitor, measure and evaluate the processes
11. Determine opportunities for improvement in processes and quality management system
12. Makes it easier for the Service industry with the word product replaced by goods and services.
13. Determine the amount of documented information on processes.

Mandatory documents and records required by ISO 9001:2015
Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes.):

Scope of the QMS (clause 4.3)
Quality policy (clause 5.2)
Quality objectives (clause 6.2)
Criteria for evaluation and selection of suppliers (clause 8.4.1)
And, here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):

Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
Records of training, skills, experience and qualifications (clause 7.2)
Product/service requirements review records (clause 8.2.3.2)
Record about design and development outputs review* (clause 8.3.2)
Records about design and development inputs* (clause 8.3.3)
Records of design and development controls* (clause 8.3.4)
Records of design and development outputs *(clause 8.3.5)
Design and development changes records* (clause 8.3.6)
Characteristics of product to be produced and service to be provided (clause 8.5.1)
Records about customer property (clause 8.5.3)
Production/service provision change control records (clause 8.5.6)
Record of conformity of product/service with acceptance criteria (clause 8.6)
Record of nonconforming outputs (clause 8.7.2)
Monitoring and measurement results (clause 9.1.1)
Internal audit program (clause 9.2)
Results of internal audits (clause 9.2)
Results of the management review (clause 9.3)
Results of corrective actions (clause 10.1)